01 1Boryung Pharmaceutical Co. , Ltd.
02 1LABORATORI ALCHEMIA SRL
01 2Alacepril
01 1Italy
02 1South Korea
Registration Number : 220MF10056
Registrant's Address : 136, Changgyeonggung-ro, Jongno-gu, Seoul, Korea
Initial Date of Registration : 2008-02-08
Latest Date of Registration : 2008-02-08
Registration Number : 218MF10675
Registrant's Address : Via San Faustino, 68 20134 MILANO-Italy
Initial Date of Registration : 2006-07-24
Latest Date of Registration : 2021-10-21
A Alacepril manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Alacepril, including repackagers and relabelers. The FDA regulates Alacepril manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Alacepril API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Alacepril manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Alacepril supplier is an individual or a company that provides Alacepril active pharmaceutical ingredient (API) or Alacepril finished formulations upon request. The Alacepril suppliers may include Alacepril API manufacturers, exporters, distributors and traders.
click here to find a list of Alacepril suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Alacepril Drug Master File in Japan (Alacepril JDMF) empowers Alacepril API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Alacepril JDMF during the approval evaluation for pharmaceutical products. At the time of Alacepril JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Alacepril suppliers with JDMF on PharmaCompass.
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